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Trial record 37 of 326 for:    clonidine

Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02181543
Recruitment Status : Completed
First Posted : July 4, 2014
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Alex Sandro Rolland de Souza, Professor Fernando Figueira Integral Medicine Institute

Brief Summary:
The purpose of this study is to determine efficacy of intraoperative clonidine to prevent postoperative agitation in pediatric anesthesia with sevoflurane.

Condition or disease Intervention/treatment Phase
Is an Only Child Drug: Clonidine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.
Actual Study Start Date : August 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Clonidine
Clonidine 1μg/Kg, IV, single dose, anesthesia intraoperative.
Drug: Clonidine
1μg/Kg, IV (in the vein) intraoperative. Number of Cycles: single dose.

No Intervention: No Clonidine
Usual care of Instituto de Medicina Integral Prof. Fernando Figueira.



Primary Outcome Measures :
  1. Postoperative agitation [ Time Frame: 6 hours ]
    Postoperative agitation will be assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED).


Secondary Outcome Measures :
  1. Duration of postoperative agitation [ Time Frame: 6 hours ]
    Time in minutes.

  2. Need for post-anesthetic drugs for treatment of agitation [ Time Frame: 6 hours ]
    Use of any drugs, such as sedatives, opioids, anti-inflammatory or anti-emetic for improvement agitation.

  3. Any occurrence of post-anesthesia accidents: falls, bruises or disconnection of catheters [ Time Frame: 6 hours ]
    If any accident occurs in the recovery room, and postoperative (falls, bruises) disconnection of intravenous catheter or injuries.

  4. Drowsiness [ Time Frame: 6 hours ]
    Clinical evaluation: patient awake, awake, alert or patient under hypnosis.

  5. Parental satisfaction. [ Time Frame: 24 hours ]
    As parents answer the question if you are satisfied with the procedure performed, excluding other problems occurred in the hospital.



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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 2 - 12 Years.
  • Need for tonsillectomy / adenotonsillectomy.
  • Physical status of the American Society of Anesthesiologists (ASA) 1, 2 or 3.
  • Anestesia geral com sevoflurano.
  • Use of Intraoperative dipyrone, 30-50mg/Kg, IV.

Exclusion Criteria:

  • Changes in consciousness.
  • Neurological Deficit.
  • Use of another drug as medication before anesthesia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02181543


Locations
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Brazil
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Recife, Pernambuco, Brazil, 50.070-550
Sponsors and Collaborators
Professor Fernando Figueira Integral Medicine Institute
Investigators
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Principal Investigator: Alex SR Souza, PhD Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Study Chair: Fernando A Souza Júnior, MD Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Study Chair: Tania CM Couceiro, MD Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Study Chair: Ítalo GM Santos, Student Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Study Director: Luciana C Lima, PhD Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Alex Sandro Rolland de Souza, Professor, Professor Fernando Figueira Integral Medicine Institute
ClinicalTrials.gov Identifier: NCT02181543     History of Changes
Other Study ID Numbers: U1111-1157-8852
First Posted: July 4, 2014    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017
Keywords provided by Alex Sandro Rolland de Souza, Professor Fernando Figueira Integral Medicine Institute:
Clonidine
Psychomotor agitation
Anesthesia recovery period
Tonsillectomy
Child, preschool
Additional relevant MeSH terms:
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Clonidine
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Anesthetics
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action